Pharmaceutical Jurisprudence

1. Lecturer
Dinesh Kumar Yadav
BPharm , MPharm(P.U)
NPC No:G-1715
Department of Pharmacy
School of Health Science Purbanchal University
Goathgaun ,Morang
Drug Manufacturing Code 2041,(1984)

2. Drug Manufacturing Code 2041 (1984 AD)
Date of Publication in Nepal Gazette : 2041/04/11
As Government of Nepal has implemented the following code on Manufacturing of
Drugs for the purpose of rule 11 of the Drug Registration Regulation 2038 (1981) ,
the public has been informed by this notice.

3. Drug Manufacture Code 2041 (1984)
1.Short Title and Commencement
2.Definition
3.Obligation to follow the code
4.Location of the manufacture premises
5.Requirement for manufacture premises
6.Necessary Equipment for manufacture of drugs
7.Raw Materials and Record of Raw Materials
8.Manufacture
9.Quality Control
10.Equipment and Means required for quality control of drug
11.Process of Quality Control
12.Record of Test Analysis
13.Packing and Labeling
14.Manufacturer’s records for sale and Distribution
15.Other Records
16.Technical Manpower
17.Miscellaneous

4. 1.Short Title and Commencement
1. This code may be called the “ Code on Manufacture of Drugs”.
2. This code shall come into force immediately.

5. 2.Definitions
• Unless the subjects or the context otherwise specified ,in this codes” Persons”
means the manufacturer and the owner of the industry established in pursuant
to drug act 2035( 1978) and Drug Registration Regulation 2038 (1981).

6. 3.Obligation to follow the code
1. Every person is obliged to follow this code .
2. Behavior in contravention to the provision of this code ,shall be convicted as
failure to comply with this code.

7. 4.Location of the manufacturing Premises
• The factory of manufacturing should not be situated in a place:
a. Away from public toilet and dumping place
b. Free from odour , smoke and dirt.

8. 5.Requirement for Manufacturing Premises
1. General Arrangement :The building used for manufacture of drugs should have
at least the following facilities :
a. Sufficient quantity of water supply and good ventilation for fresh air
b. Sufficient electricity or other source of energy.
c. Necessary arrangement for disposal of contaminated air and gases.
d. Hygienic working environment.
e. Necessary arrangement to dispose ,bury , destroy or render the water or residing of
manufacture harmless.
f. Toilet ,enough water , provision for taking both.
g. Necessary arrangements and equipment to control possible fire hazard.
h. Separate facilities for storage of raw materials ,production of drug , packing materials for
drugs ,storage of finished products.
i. Necessary arrangement to maintain cleanliness in production areas.

9. 2. Special Arrangement: In addition to the general arrangement mentioned above , there
must be provision to prevent the entry of unrelated persons , and to keep necessary
precaution for freedom from dust ,insect and micro-organism in all areas specially in the area
used for the mentioned in the production rooms . Such rooms should have the following
provisions:
a. A facility with separate rooms for different activities such as storage of raw materials
,washing of containers , preparation of solution ,filling ,sealing ,sterilization of i.v fluids
,packing ,labeling and storage of finished products .
b. The production of parenteral requires the following additional arrangement in addition to
above.:
1. A clean room which should be easily washable smooth floor and walls and an in previous ceiling .
2. The room for preparation of solutions should be completely clean and with washable waterproof
floors, walls and ceilings.
3. The filling and sealing room should be washable with disinfectant and have a waterproof floor , walls
and ceiling .This room should be under positive pressure with air locks and a filters to prevent the entry
of a dusty air from the outside.
4. (a) The filling and sealing rooms, for parenteral products which are not subject to terminal sterilization
should have provision for very strict control of micro-organisms along with the provisions mentioned as
above (3).E.g. provision should for fumigation.

10. (b)For products subjects to terminal sterilization the provision should be as per mentioned under(3)
(C) Provision should be made to store raw materials and prepared drugs in such manner that quantity thereof is
not affected adversely.
6.Necessary equipment for manufacture of drugs :
The manufacturer should have the following equipment's for manufacturing of the
following dosage form.
a. Liquid (Elixir , Mixture, Syrup ,Lotion , Liniments drops, Spray and Galenicals )
b. For ointments and pastes
c. For tablets and capsules
d. For parenteral Products
7. (Materials ):
The Standard of each raw materials used for manufacture of drugs should accompany with the standards
mentioned in the pharmacopoeia or other treatise or related standards:
a. Identification test for materials
b. Test certificate by quality control
c. The raw materials under quality control or those declared as sub standard should be store separately
preventing their possible use during manufacture.
d. The raw materials under quality control should be exercised to prevent intermixing with other
substances.

11. 7(2) Record of Raw Materials :
Such records should indicate the name ,source (manufacture and batch no.)
quantity received an date , date of analysis , storage condition ,date of release from
quality control , quantity used in production ,quantity remaining in the store of the
raw materials.
8. Manufacture :
Production should be undertaken under the responsibility and supervision of an
expert as mentioned in section 13 of this code . Attention should be paid to the
following points during manufacture of drugs.
a. Related equipment's ,tools and the room should be thoroughly cleaned and if
required sterilized before using them in production.
b. All equipment , means machines and containers should be clearly labeled
regarding the purpose for which it is being used throughout production.
c. The person involved in production should wear proper clothes ,shoes,cap,mask
,gloves, and safety goggles ,all the exposed parts of the body.

12. d. Hands should be washed with disinfectant solution before entering the
production room where manufacture of parenteral is carried out.
e. The personnel should be free from contagious disease . Health checks of the
personnel should be undertaken from to time.
f. Written production chart: Instruction of the process and procedures related to
production should be prepared under the supervision of the responsible persons .
Such types of production charts should contain the following methods and
directions for each drugs.
1. Name of the drug manufactured ,dosage form , type and quantity of the active
ingredients and formula of the product.
2. Procedure of manufacture of the drugs.
3. Clearly labeled batch no. and name of the drug on each storage container used at various
stages of production.
4. Identification of raw materials used and for production , their standards and quantity
shall be identifiable at all stages during manufacture till finished products.
5. Quality control to be undertaken during production stages , the test or analytical methods
details of the branch responsibilities for it and the name of related persons should be
clearly mentioned.
6. Direction related to storages of finished and unfinished goods.

13. g. In any room where production will be carried out unrelated drugs and materials .if is
there any, should be kept separately in such a way that they are not taken.
h. Drugs which are sterilized ,should be produced continuously by required , methods in a
proper ways. Each materials used for that products should be labeled indicating whether
it is sterilized or not.
i. A separate room should be provided for weighing mixing ,pulverizing ,tabulating and
capsulation of poisonous drugs and antibiotics ,this room should have separated
ventilation.
J. Batch record of production : The production records should contain complete details of
each batch . They should contain full details of whether the production method had been
followed or not, whether analysis has been carried out or not, if carried out the name of
the analyst . A separate batch record should be maintained along with the production
records and such records should be kept securely for at least 5 years . The batch records
should contain the following particulars :
1. Name , dosage form and formula of the drug.
2. Date on which production was started.
3. Date on which production was completed
4. Batch no or its indication
5. Quantity and identification test used at each step , precautions taken and any note of unusual
happening or points of observed.
6. Theoretical and practical yield at each stage.

14. 7.Regularly signed records showing the production method used at each steps ,precaution taken
and any note of unusual happening or points of observed.
8.The procedures used to control production and its results.
9.Label specimen
10.Duration and machineries used in production and description of packing materials.
11.Signature of the incharge responsible for manufacture and the date.
12.Quality control report showing the attainment of standard to related batch of the drug.
13.Finished goods should be labeled as specified by law.
14.Date of manufactured and expiry date , if any must be mentioned on the label on the finished
goods.

15. 9. Quality Control:
Each industry involved in manufacture of drugs should have an autonomous
quality control laboratory . Its primary function should be to test the quality,
maintenance of standard and stability of each raw materials used for manufacture
of drugs ,products in process , and finished goods , and to provide requisite help in
the maintenance of quality during production . There should be sufficient staffs
and equipment in the laboratory for the purpose of testing and analysis of both in-
process and finished products .Under this management , the minimum quality
control determined by the department would be undertaken by the concerned
industry and other special quality analysis can be performed by other laboratories
approved by the department .
10.Equipment and means required for quality control of drugs:
The methodology and equipment's required for evaluation of drugs its quality and
standard as prescribed in the recognized pharmacopoeia or other treatise and
standards recognized by the department should be strictly followed .

16. 11.Process of quality of Control :
The following will be the duties required to be performed by an analyst responsible for
quality control :
a) Preparation of detailed method of analysis for each drug and information on testing.
b) Approval of raw materials used in each batch in manufacturing .
c) Test or analysis of semi-finished products for each batch and approval to go ahead in production.
d) Approval for storage ,distribution and sale after testing and analysis of the finished products.
e) To control the materials to be used to pack and label drugs and materials to be used in the final
packing and give approval to bring them in use.
f) To evaluate the situation of storage of any raw materials , semi processed materials or produced
drugs.
g) Evaluation of the quality and stability of raw materials ,semi finished products.
h) Determination of the expiry date and possible changes during storage of the drugs.
i) Fix internal method for quality control.
j) The quality controller should have a good sense of responsibility should draw sample properly ,
label it and should keep a portion of sample for the possible analysis in the future.
k) Marketed products should be also drawn sample from the market , time to time to access the
quality and stability studies should be performed then.

17. 12. Record of test of analysis :
a) Results of analysis of raw materials and production process made a various stages and decision as
to whether final evaluation of the produced drugs and test and analysis of the standards of the
drugs concerned have been performed or not.
b) Details of methods and standards used as per pharmacopeias or other approved methods of
analysis.
c) Signature of the analyst and the date when it is performed.
d) Signature of the expert responsible for rechecking and the date.
13. Packing and labeling :
Only related persons and some other related in his presence can enter the store where labels and
packing materials are stored. Only required quantities of label and packing materials should be
released from the store to prevent possible mistakes in packaging and labeling. Only concerned store
in charge should handle those materials .Approval for packaging and labeling should be obtained from
the quality controller before the packaging and labeling of each batch.
Only concern store in charge should take out packaging and labeling materials from the store after
carefully checking the demand sheet from the production in charge. The demand sheet should show
clearly the signature of the persons requesting materials and its quantity along with date of issue. The
person should taken calculate the labels and packing materials present in the store by deducting the
requested quantity with that of balance in the store. The labels and packaging materials unsuitable
for use undertaken if any labels or packaging materials are lost.

18. Label on finished good should contain the following particulars :
a. Name and quantity of the generic and Brand name of drugs
b. Product licensce No.
c. List of active ingedients used in the formula
d. Batch no.
e. Date of manufacture
f. Expiry date (if necessary)
g. Information on recommended storage conditions and precautions
h. Method of administration
i. Name and addresses of manufacturer
j. Category of drug
k. Name of the drug in ‘’Dev Nagari” script in.
14.Manufacturer’s records for sale and distribution
Clear records of each drug manufactured should be kept before release for sale and distribution . Such
records should be helpful if recall or any drug is deem necessary.

19. 15.Others records : Necessary records should be maintained if any drugs which are
recalled ,returned ,inward , expired ,destroyed or of sub-standard quality on
manufacture .The record of decision of the re-processing and date, the processing
methodology and resale should be kept ,if such drugs have been reprocessed for
the purpose of sale and distribution.
16.Technical Manpower:
1. Any person establishing a drug industry should engage at least one expert with the
following qualification for the purpose of supervision of the production process.
a. Holder of a degree in pharmacy or
b. Holder of a master degree in pharmaceutical chemistry or
c. Holder of a master degree in chemistry with three years if practical experience in manufacture of
drugs.
2. Any person establishing a drug industry should engage at least one expert with the
following qualifications for the purpose of supervision of quality control.
a. Holder of degree in pharmacy or
b. Holder of a Master degree in Pharmaceutics and Chemistry.

20. 17. Miscellaneous:
a) All record books should be maintained and stored securely.
b) Adequate manpower for production and quality control should be maintained.
c) If any report or information is obtained stating that a manufactured drug has caused
harm or adverse effects , the manufacture should at once review the manufacturing and
quality control process and take necessary steps as deem necessary.
d) Testing , analysis and evaluation of the returned or recalled drug should be performed
before reprocessing for the purpose of resale and distribution of such drugs.

21. Assignment
• List out the necessary equipment for manufacturing of drug of section 6 as per
Drug Manufacturing code 2041(1984 AD)